"Coincidentally, associate professor Shaun Holt had published an article in the New Zealand Herald, which suggested that 'our ethical committees had become so bureaucratic and inefficient that they were unethical'. Dr Holt's article was rebutted by professor Tim Dare, who claimed that New Zealand ethics committee process' was the best in the world. However, there was an admission by others that it needed a streamlined electronic process," Dr Hutchison added.

There was also a perception that the New Zealand clinical trials industry had become less attractive because of relationships between some pharmaceutical companies and the drug funding agency Pharmac. "The most talked about example was when Pfizer withdrew $50 million of funding from cancer research at Auckland University," he says.

He presented the terms of reference to the national government caucus, which accepted them after consultation with key figures in the industry and the government. "They were in turn implemented unanimously by all political parties, represented in the Health Select Committee. Public submissions were called for and, 32-out-of-the-58, were heard by the committee. We received advice from the Ministry of Health, the Ministry of Science and Innovation, and specialist advice from Mr David Clarke and Dr Neil Domigan from Cranleigh Health (Cranleigh Merchant Bank)," he explains.

This resulted in the report in June 2011. The government responded within three months and agreed to the main recommendations. The key recommendations to be acted on urgently (within 12 months of the report's presentation), included simplifying and streamlining ethical review processes; promoting collaboration between the government departments to coordinate the system; developing a national health research action plan to foster innovation and commercialization; and developing a framework for clinical trial research throughout district health boards, to be facilitated by a hub.

Things have improved since the recommendations were made. Dr Hutchison himself agreed to that. "I have no doubt that the environment for carrying out clinical trials has already changed for the better, but it is vital that we continue to aspire to be the best place in the world for the type of trials that suit our population," he revealed.

1Comment

Dr Hutchison's 2011 report was timely. He drew attention to, amongst other things, the benefits to: the participants in clinical trials, the health system generally, higher education and the economy. He quoted a New Zealand Trade and Enterprise [NZTE]-sponsored paper on the biotech industry which showed that (1) for every $1m spent, a further $1.03m was created in the wider economy resulting in total output of $2.03m; (2) the multiplier effect for every dollar in terms of GDP was 1.95 and (3) the multiplier for jobs was 3.41. The not-unreasonable assumption was made that this general pattern would be reflected in the clinical trials 'sector'.
Currently in New Zealand we are endeavouring to develop a cohesive Regenerative Medicine [RM] industry. The web page http://www.cmdt.org.nz/research-themes/ provides a general profile of RM which embraces clinical trialling in NZ as an integral component of its structure. It doesn't, I think, require a huge leap of imagination to visualise some of the benefits of having a strong and expanding sector. There are, of course, the overall outcomes noted in the NZTE study. But one might add the engendering of confidence on the part of biomedical researchers and their sponsors that products-to-be can be tested readily and affordably; the encouragement, springing from this, to continue with the necessary lab-end work; and the immediacy and colleagiality of researcher-clinician/trialler contact and the efficiencies arising. One could also mention the relative manageability [and low costs?] of carrying out trials in a small population and the accessibility of a wide range of ethno-cultural groups, the major ones of which encompass numbers suitable for robust study.
The clinical trialling sector in NZ is a health, education and economic driver-in-waiting. Decision-makers and influencers need to recognise this and take the necessary action to help ensure the growth and further development of the sector.
Cheers
Reg